Cleared Traditional

K801742 - NEW FINE MODEL ENT TREATMENT UNIT

K801742 is the FDA 510(k) clearance for NEW FINE MODEL ENT TREATMENT UNIT by Jedmed Instrument Co.. It is a Class 1 Ear, Nose, Throat device (product code ETF) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K801742 · Jedmed Instrument Co. · Ear, Nose, Throat device
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Aug 1980
Decision
19d
Days
Class 1
Risk

K801742 is an FDA 510(k) clearance for the NEW FINE MODEL ENT TREATMENT UNIT. Classified as Unit, Examining/treatment, Ent (product code ETF), Class I - General Controls.

Submitted by Jedmed Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1980 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5300 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jedmed Instrument Co. devices

Submission Details

510(k) Number K801742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1980
Decision Date August 13, 1980
Days to Decision 19 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 89d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ETF Unit, Examining/treatment, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ETF Unit, Examining/treatment, Ent

All 23
Devices cleared under the same product code (ETF) and FDA review panel - the closest regulatory comparables to K801742.
NOBLE MODEL DOUBLESIDED TREATMENT UNIT
K801739 · Jedmed Instrument Co. · Aug 1980
TREATMENT UNIT FOR DOCTOR'S ROUNDS
K801740 · Jedmed Instrument Co. · Aug 1980
PRETTY MODEL ENT TREATMENT UNIT
K801741 · Jedmed Instrument Co. · Aug 1980
ATMOS ENT TREATMENT SYSTEM SERVANT 3
K791934 · Jedmed Instrument Co. · Oct 1979
ATMOS ENT CABINET PRACTICA 3
K791935 · Jedmed Instrument Co. · Oct 1979
ATMOS ENT CABINET PRACTICA 2
K791936 · Jedmed Instrument Co. · Oct 1979